Supplement may offer a statin alternative for some

NEW YORK (Reuters Health) - Red yeast rice supplements may offer a cholesterol-lowering alternative to people who've suffered muscle pain as a side effect of statins, a small study suggests.

Researchers found that among 43 people who'd stopped using statins due to muscle pain, most were able to use either red yeast rice or the cholesterol drug pravastatin (Pravachol) for 12 weeks without suffering the side effect again.

The supplement and the statin were also similarly effective at lowering "bad" LDL cholesterol, the researchers report in the American Journal of Cardiology.

Used for centuries in parts of Asia as a medicine and food garnish, red yeast rice has become an increasingly popular over-the-counter supplement in the U.S. in the past few years.

The product, which is made by fermenting red yeast over rice, contains statin-like compounds called monacolins -- including one, monacolin K, which is structurally identical to the cholesterol drug lovastatin (Mevacor).

Studies have long suggested that red yeast rice extracts can lower cholesterol. These latest findings suggest that both the supplement and pravastatin are potential options for people who have suffered muscle pain from statin use, senior researcher Dr. David J. Becker told Reuters Health.

However, while red yeast rice is available over-the-counter, patients should still talk with their doctors before using it, according to Becker, a cardiologist at Chestnut Hill Hospital and the University of Pennsylvania Health System in Philadelphia.

Nor should people with existing heart disease swap their statins for red yeast rice, he advised. Statins have been shown to lower the risks of heart attack, stroke and death from heart disease; the benefits of red yeast rice beyond lowering cholesterol are not yet clear.

For their study, Becker and his colleagues randomly assigned 43 patients with high cholesterol to take either red yeast rice capsules or pravastatin every day for 12 weeks. The supplement group took four 600-milligram capsules twice per day, while the pravastatin group took 40 mg a day.

Both groups also attended a program on lifestyle change.

By the end of the study, 1 of 21 patients on red yeast rice had stopped the treatment due to muscle pain, as had 2 of 22 patients on pravastatin. LDL levels fell by an average of 30 percent among supplement users, and by 27 percent among pravastatin users.

According to Becker, the low rate of muscle side effects in the pravastatin group is in line with other research showing that among statins, pravastatin and fluvastatin (Lescol) tend to be better tolerated.

When it comes to using red yeast rice for lowering cholesterol, the researcher noted that a continuing obstacle is the lack of regulation.

The Food and Drug Administration does not regulate dietary supplements as it does drugs, and consumers cannot be sure of what they are getting when they buy an herbal remedy.

A 2008 study by ConsumerLab, an independent testing company, found that 10 brands of red yeast rice supplements varied widely in their potency, and four were contaminated with citrinin, a potentially kidney-damaging substance that can form as a byproduct of the fermentation process.